Patients with ESRD undergoing dialysis with severe hyperparathyroidism and low bone mass Urological and Genital Diseases
Conditions
Interventions
The effect of denosumab on vascular calcification in patients with chronic renal failure patients with low bone mass has been a subject of interest. The purpose of this investigation is to determine c
Sponsors
Kaohsiung Veterans General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In accordance with the regulatory guidelines, the patients were enrolled in the peritoneal dialysis or hemodialysis patient groups. Key inclusion criteria were age >18 years, normal laboratory tests at screening and baseline, and clinically acceptable physical examination and electrocardiograph results at screening. The study protocol was therefore amended to include requirements for daily supplementation of calcium and calcitriol according to standard dialysis guideline in all subjects with ESRD with low bone mass and a history of iPTH>800 pg/mL. All of the patients had been receiving renal replacement therapy, had various degrees of osteopenia with bone mineral densities, which were measured by dual-energy X-ray absorptiometry (DEXA); furthermore, all patients had a forearm, femoral neck or lumbar spine T score lower than -2.5 SD, indicative of low bone mass.
Exclusion criteria
Exclusion criteria: Key exclusion criteria were known sensitivity to any study treatment, unstable medical condition, history of malignancy, active infection, pregnancy, lactation, nursing, parathyroidectomy with parathyromatosis, drug abuse at screening, and aluminum levels >20 µg/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coronary and abdomen aorta calcification measured using fast-gated helical computed axial tomographic imaging at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Osteopenia measured using dual-energy X-ray absorptiometry (DEXA) at baseline and 6 months | — |
Countries
Taiwan
Outcome results
None listed